Label: DRIMINATE- dimenhydrinate tablet
- NDC Code(s): 0904-2051-12, 0904-2051-59
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 18, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
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Directions
- to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity
adults and children 12 years and over 1 to 2 tablets every 4-6 hours; do not exceed 8 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years ½ to 1 tablet every 6-8 hours; do not exceed 3 tablets in 24 hours, or as directed by a doctor children 2 to under 6 years ½ tablet every 6-8 hours; do not exceed 1½ tablets in 24 hours, or as directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
MAJOR®
NDC 0904-2051-59
*Compare to the Active Ingredient in Dramamine® Original Formula
Driminate™
Dimenhydrinate USP, Antiemetic
For Nausea, Dizziness and Vomiting from Motion Sickness
100 Tablets
50 mg EACH
Use as DirectedTAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine® Original Formula.
50844 REV0518M19812Distributed by
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA M-17 Rev. 08/18
Re-order No. 700621major 44-198
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INGREDIENTS AND APPEARANCE
DRIMINATE
dimenhydrinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-2051 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M, 8-CHLOROTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code 44;198 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-2051-59 1 in 1 CARTON 12/01/1992 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:0904-2051-12 1 in 1 CARTON 12/01/1992 11/15/2020 2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 12/01/1992 Labeler - Major Pharmaceuticals (191427277) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(0904-2051) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(0904-2051) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(0904-2051) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(0904-2051) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(0904-2051)